Spots Global Cancer Trial Database for Sorafenib Dose Escalation in Renal Cell Carcinoma

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Trial Identification

Brief Title: Sorafenib Dose Escalation in Renal Cell Carcinoma

Official Title: A Phase II, Multi-centre, Open-label Study to Assess the Efficacy, Safety, Tolerability and Pharmacokinetics of Intrapatient Dose Escalation of Sorafenib as First Line Treatment for Metastatic Renal Cell Carcinoma.

Study ID: NCT00618982

Conditions

Carcinoma, Renal Cell

Interventions

Sorafenib (Nexavar, BAY43-9006)

Study Description

Brief Summary: Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of advanced kidney cancer. It is also currently being tested in various other cancers. Sorafenib works by stopping the development of new cancer cells and new blood vessels. By stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents the growth of kidney cancer tumors. This is an "open-label" study which means that the patient, the doctor and Bayer Healthcare will know what tablets the patient is taking. All patients in this study will receive sorafenib tablets. Sorafenib is taken orally as a tablet (two tablets are taken twice a day). Treatment with sorafenib will continue until the patient's tumor grows larger or spreads further or if the patient has intolerable side effects. The dose of sorafenib that the patient will receive in the study will increase at certain points during the patient's treatment, as long as the patient is not experiencing side effects and the patient's tumor has not grown.

Detailed Description: Issues on Outcome Measure "Safety and tolerability" will be addressed in the Adverse Events section.